TY - JOUR
T1 - Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: A DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey
AU - EUSTAR co-workers
AU - Blagojevic, J.
AU - Bellando-Randone, S.
AU - Abignano, G.
AU - Avouac, J.
AU - Cometi, L.
AU - Czirják, L.
AU - Denton, C. P.
AU - Distler, O.
AU - Frerix, M.
AU - Guiducci, S.
AU - Huscher, D.
AU - Jaeger, V. K.
AU - Lóránd, V.
AU - Maurer, B.
AU - Nihtyanova, S.
AU - Riemekasten, G.
AU - Siegert, E.
AU - Tarner, I. H.
AU - Vettori, S.
AU - Walker, U. A.
AU - Allanore, Y.
AU - Müller-Ladner, U.
AU - Del Galdo, F.
AU - Matucci-Cerinic, M.
N1 - Funding Information:
This study, as part of the DeSScipher project, was supported by the European Community’s Framework Programme 7 [FP7-HEALTH-2012.2.4.4-2 Observational trials in rare diseases]; grant agreement N° 305495.
Funding Information:
The authors report personal fees and non-financial support by the European Community’s Framework Program 7 [FP7-HEALTH-2012.2.4.4-2 Observational trials in rare diseases]; grant agreement no. 305495. OD: Consultancies, speaking fees, and honoraria < $10,000: AnaMar, Bayer, Boehringer Ingelheim, Catenion, CLS Behring, ChemomAb, Roche, GSK, Inventiva, Italfarmaco, Lilly, medac, Medscape, Mitsubishi Tanabe Pharma, MSD, Novartis, Pfizer, Sanofi, UCB Consultancies, speaking fees, and honoraria > $10,000: Bayer, Böhringer. Patents, licenses, or licensing fees: Patent mir-29 for the treatment of systemic sclerosis licensed CPD: Consultancies, speaking fees, and honoraria < $10,000: Actelion, Bayer, Boehringer Ingelheim, Inventiva, Sanofi-Aventis, CSL Behring SV: Consultancies, speaking fees, and honoraria < $10,000: Thermofisher, Abbvie, Boehringer-Ingelheim YA: Consultancies, speaking fees, and honoraria < $10,000: Actelion, Boehringer, Roche, Sanofi, Inventiva, Medac, Bayer, BMS, Pfizer MMC: Consultancies, speaking fees, and honoraria < $10,000: Actelion, BMS, Pfizer
Publisher Copyright:
© 2019 The Author(s).
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2019/1/24
Y1 - 2019/1/24
N2 - Background: A consensus on digital ulcer (DU) definition in systemic sclerosis (SSc) has been recently reached (Suliman et al., J Scleroderma Relat Disord 2:115-20, 2017), while for their evaluation, classification and categorisation, it is still missing. The aims of this study were to identify a set of essential items for digital ulcer (DU) evaluation, to assess if the existing DU classification was useful and feasible in clinical practice and to investigate if the new categorisation was preferred to the simple distinction of DU in recurrent and not recurrent, in patients with systemic sclerosis (SSc). Methods: DeSScipher is the largest European multicentre study on SSc. It consists of five observational trials (OTs), and one of them, OT1, is focused on DU management. The DeSScipher OT1 items on DU that reached ≥ 60% of completion rate were administered to EUSTAR (European Scleroderma Trials and Research group) centres via online survey. Questions about feasibility and usefulness of the existing DU classification (DU due to digital pitting scars, to loss of tissue, derived from calcinosis and gangrene) and newly proposed categorisation (episodic, recurrent and chronic) were also asked. Results: A total of 84/148 (56.8%) EUSTAR centres completed the questionnaire. DeSScipher items scored by ≥ 70% of the participants as essential and feasible for DU evaluation were the number of DU defined as a loss of tissue (level of agreement 92%), recurrent DU (84%) and number of new DU (74%). For 65% of the centres, the proposed classification of DU was considered useful and feasible in clinical practice. Moreover, 80% of the centres preferred the categorisation of DU in episodic, recurrent and chronic to simple distinction in recurrent/not recurrent DU. Conclusions: For clinical practice, EUSTAR centres identified only three essential items for DU evaluation and considered the proposed classification and categorisation as useful and feasible. The set of items needs to be validated while further implementation of DU classification and categorisation is warranted. Trial registration: Observational trial on DU (OT1) is one of the five trials of the DeSScipher project (ClinicalTrials.gov; OT1 Identifier: NCT01836263, posted on April 19, 2013).
AB - Background: A consensus on digital ulcer (DU) definition in systemic sclerosis (SSc) has been recently reached (Suliman et al., J Scleroderma Relat Disord 2:115-20, 2017), while for their evaluation, classification and categorisation, it is still missing. The aims of this study were to identify a set of essential items for digital ulcer (DU) evaluation, to assess if the existing DU classification was useful and feasible in clinical practice and to investigate if the new categorisation was preferred to the simple distinction of DU in recurrent and not recurrent, in patients with systemic sclerosis (SSc). Methods: DeSScipher is the largest European multicentre study on SSc. It consists of five observational trials (OTs), and one of them, OT1, is focused on DU management. The DeSScipher OT1 items on DU that reached ≥ 60% of completion rate were administered to EUSTAR (European Scleroderma Trials and Research group) centres via online survey. Questions about feasibility and usefulness of the existing DU classification (DU due to digital pitting scars, to loss of tissue, derived from calcinosis and gangrene) and newly proposed categorisation (episodic, recurrent and chronic) were also asked. Results: A total of 84/148 (56.8%) EUSTAR centres completed the questionnaire. DeSScipher items scored by ≥ 70% of the participants as essential and feasible for DU evaluation were the number of DU defined as a loss of tissue (level of agreement 92%), recurrent DU (84%) and number of new DU (74%). For 65% of the centres, the proposed classification of DU was considered useful and feasible in clinical practice. Moreover, 80% of the centres preferred the categorisation of DU in episodic, recurrent and chronic to simple distinction in recurrent/not recurrent DU. Conclusions: For clinical practice, EUSTAR centres identified only three essential items for DU evaluation and considered the proposed classification and categorisation as useful and feasible. The set of items needs to be validated while further implementation of DU classification and categorisation is warranted. Trial registration: Observational trial on DU (OT1) is one of the five trials of the DeSScipher project (ClinicalTrials.gov; OT1 Identifier: NCT01836263, posted on April 19, 2013).
UR - http://www.scopus.com/inward/record.url?scp=85060511429&partnerID=8YFLogxK
U2 - 10.1186/s13075-019-1822-1
DO - 10.1186/s13075-019-1822-1
M3 - Journal articles
C2 - 30678703
AN - SCOPUS:85060511429
SN - 1478-6354
VL - 21
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
IS - 1
M1 - 35
ER -
